Can we bypass confirmatory testing of DP based on Theoretical Calc. of NDSRI's

@Raza The journey is just beginning… as we have dived and deepened into several of the discussions here in the community, the risk of nitrosamine formation is not unique to the API. It’s only one of many areas of risk.
As DP manufactured, now you need to demonstrate on ‘your own’ risk assessment, that those or any other Nitrosamines will form along the manufacturing of the DP. Think of that fish diagram bone from @lucas10mauriz post … Formulation, Unitary operations, excipients, water, packaging operation, materials, etc…

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